1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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Purpose of Study Group
SG5 has been charged with promoting convergence of regulatory requirements for evidence of the clinical safety and performance of medical devices. The group will concentrate on establishing harmonized definitions for commonly used terms (clinical investigation, clinical data, clinical evaluation and clinical evidence) as well as developing harmonized guidance on the content and format for clinical investigation reports and on how to conduct and document a clinical evaluation. The group will work closely other GHTF study groups to review existing documents to ensure that terminology is consistent and interfaces are clear and that there is a consistent approach to broader GHTF initiatives (e.g., STED).
Study Group Details
Documents
Updated 1 April 2008
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